Viewing Study NCT00360061


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Study NCT ID: NCT00360061
Status: COMPLETED
Last Update Posted: 2006-08-03
First Post: 2006-08-01
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: CBT in Adolescents With Type 1 Diabetes
Sponsor: University of Bristol
Organization:

Study Overview

Official Title: Randomised Controlled Trial of Cognitive Behaviour Therapy: Efficacy and Acceptability for Adolescents With Type 1 Diabetes.
Status: COMPLETED
Status Verified Date: 2001-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The effectiveness of cognitive behavioural therapy (CBT) for adolescents with type 1 diabetes will be tested. This structured, time-limited, problem-orientated therapy will be used to impact on psychosocial factors influencing diabetic control, with the patient and therapist working together on specific goals to develop adaptive strategies.
Detailed Description: Ninety 11-16 year olds with T1DM (duration \>1 year), attending paediatric diabetes outpatient clinics based in 4 centres in South-West England, UK, will be recruited to a randomised controlled trial of one to one sessions of CBT versus non-directive supportive counselling. Participants will attend up to 6 sessions (weekly) with either a CBT therapist or a counsellor, with 2 further sessions at 6 and 12 months. Follow up will continue for 12 months post intervention. HbA1c is the primary outcome measure. Psychological measures will also be measured.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
DUK grant BDA: RD01/0002114 None None View